(96 days)
The QUANTA Lite™ CCP3 IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP3 (Cyclic Citrullinated Peptide 3) antibodies in patient sera or citrated or EDTA plasma. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.
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This document is a 510(k) premarket notification decision letter from the FDA for the "QUANTA Lite™ CCP3 IgG ELISA" device. It does not contain details about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment.
The letter primarily addresses the substantial equivalence determination for marketing the device. The 510(k) summary, which would contain such study details, is a separate document typically submitted with the 510(k) application.
Therefore, I cannot provide the requested information based on the provided text.
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).